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Reanálisis de los datos de ensayos clínicos aleatorizados.
Shanil Ebrahim1, Zahra N Sohani2, Luis Montoya3
1Stanford Prevention Research Center, Department of Medicine, Stanford University, Stanford, California2Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada3Department of Anesthesia, McMaster University4Depa.
JAMA
|September 10, 2014
Resumen
Los reanálisis publicados de ensayos clínicos aleatorizados (ECA) son raros y pocos son independientes. Muchos reanálisis alteran los hallazgos, lo que afecta a las recomendaciones de tratamiento del paciente.
Área de la Ciencia:
- Metodología de la investigación médica Metodología de la investigación médica.
- Análisis de ensayos clínicos Análisis de ensayos clínicos
- Síntesis de la evidencia La síntesis de la evidencia.
Sus antecedentes:
- Los reanálisis de los datos de ensayos clínicos aleatorizados (ECA) son cruciales para verificar los hallazgos informados.
- La evaluación de la validez de los resultados de los ensayos mejora la confianza de la comunidad científica y la integridad de los datos.
Objetivo del estudio:
- Para identificar y caracterizar los reanálisis publicados de los datos de ECA.
- Evaluar la independencia del autor y los cambios en la interpretación con respecto al tratamiento del paciente.
- Comprender el impacto de los reanálisis en las conclusiones clínicas.
Principales métodos:
- Búsqueda electrónica sistemática de MEDLINE para las reanálisis de RCT.
- Extracción de datos independiente por parte de cuatro especialistas.
- Comparación de ECA originales con sus reanálisis publicadas.
Principales resultados:
- Se identificaron 37 reanálisis elegibles en 36 publicaciones.
- Los reanálisis comúnmente diferían en los métodos estadísticos (18) y en las definiciones de los resultados (12).
- 13 reanálisis (35%) dieron como resultado interpretaciones alteradas de las recomendaciones de tratamiento de los pacientes.
Conclusiones:
- Los reanálisis de ECA publicados son poco frecuentes, con una ejecución independiente limitada.
- Una proporción significativa de los reanálisis conducen a conclusiones modificadas sobre la selección del paciente para el tratamiento.
- Los reanálisis resaltan la importancia de la transparencia de los datos y la verificación independiente en la investigación clínica.
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